Pulsenmore

Pulsenmore Receives FDA Approval for First Home-Use Ultrasound Device for Pregnant Women

- Israeli medical device company Pulsenmore has received FDA marketing approval for its at-home ultrasound device, marking the first time such approval has been granted for an ultrasound device intended for home use by pregnant women. - The Pulsenmore ES device allows expectant mothers to perform ultrasound scans at home either through a smartphone-connected cradle or under remote medical professional guidance via telemedicine. - The FDA approval follows the rigorous 510k de novo pathway, establishing Pulsenmore as the predicate device for future competitors in this new product category. - With approximately 3.6 million births occurring annually in the United States, the device addresses critical access issues in prenatal care, particularly for women in remote areas or those requiring frequent high-risk pregnancy monitoring.